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Clinical Trial NCT07481903 for Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline), Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline (SCD) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors 228 Randomized

Not yet recruiting
Clinical Trial NCT07481903 is an interventional study for Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline), Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline (SCD) and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2026 and continue until the study accrues 228 participants. Led by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, this study is expected to complete by July 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 19, 2026.
Brief Summary
This clinical trial aims to assess whether electroacupuncture (EA) can alleviate the psychoneurological symptom cluster (including pain, fatigue, insomnia, anxiety, depression and subjective cognitive decline) in breast cancer survivors, and to evaluate the safety of this therapy.

Researchers will conduct a randomized controlled trial of electroacupuncture (EA) as compared to sham electroacupuncture (SA) in breast c...

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Official Title

Effect of Acupuncture on Psychoneurological Symptom Cluster in Breast Cancer Survivors

Conditions
Psychoneurological Symptom Cluster(Pain, Insomnia, Anxiety, Fatigue, Depression, Subjective Cognitive Decline)PainInsomniaAnxietyFatigueDepressionSubjective Cognitive Decline (SCD)
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 7252224
NCT ID Number
NCT07481903
Start Date (Actual)
2026-04
Last Update Posted
2026-03-19
Completion Date (Estimated)
2028-07
Enrollment (Estimated)
228
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Psychoneurological Symptom Cluster
Breast Cancer
Acupuncture
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEA group
Participants undergo 16 sessions of electroacupuncture twice weekly over 8 weeks.
electroacupuncture
A semi-standardized protocol is used for participants in the EA group, which includes (1) standardized acupoints (Midline: Baihui \[GV20\], Shenting \[GV24\], Qihai \[CV6\], Guanyuan \[CV4\]; Bilateral: Fengchi \[GB20\], Taiyang \[EX-HN5\], Zusanli \[ST36\], Hegu \[LI4\], Taichong \[LR3\]); and (2) additional acupoints (Sishencong \[EX-HN1\] and bilateral Benshen \[GB13\] for anxiety/depression/subjective cognitive d...Show More
Sham ComparatorSA group
Participants undergo 16 sessions of sham electroacupuncture(noninsertive simulated acupuncture and sham electrical stimulation) twice weekly over 8 weeks.
sham electroacupuncture
In the SA group, noninsertive simulated acupuncture and sham electrical stimulation(30-second transient device activation instead of 30-minute continuous stimulation) are used, while maintaining the same treatment duration and course as the EA group. Blunt needles are placed on 12 acupoints (Bilateral: Fengchi \[GB20\], Taiyang \[EX-HN5\], Zusanli \[ST36\], Hegu \[LI4\], Taichong \[LR3\]; Midline: Qihai \[CV6\], Guan...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Response rate of psychoneurological symptom cluster (after 8 weeks of treatment)
The response rate is defined as the proportion of participants classified as responders. Improvement in each of the six psychoneurological symptoms is assessed using the following validated instruments: pain is measured by the Visual Analogue Scale (VAS); sleep quality by the Pittsburgh Sleep Quality Index (PSQI); fatigue by the Chinese version of the Brief Fatigue Inventory (BFI-C); anxiety and depression by the Hospital Anxiety and Depression Scale (HADS); and subjective cognitive function by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog). A participant is deemed a responder if the post treatment improvement from baseline meets or exceeds the minimum clinically important difference (MCID) for at least two of the six symptoms.
Week 8
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Response rate of psychoneurological symptom cluster (after 4 weeks of treatment and 12-week follow-up)
The definition and calculation method of the response rate are consistent with those of the primary outcome measure.
Week 4, Week 12
Change from Baseline in the Functional Assessment of Cancer Therapy-Breast (FACT-B) Score
Quality of life is measured by the Chinese version of FACT-B, which consists of 36 items. The total scale score ranges from 0 to 144, with higher scores indicating better quality of life.
Baseline (Week 0), Week 4, Week 8, Week 12
Change from Baseline in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Total and Subscale Scores
The FACT-Cog is a 37-item self-response measure to assess cognitive concerns of cancer patients, consisting of four subscales: Perceived Cognitive Impairments (20 items, range 0-80), Comments from Others (4 items, range 0-16), Perceived Cognitive Abilities (9 items, range 0-36), and Impact on Quality of Life (4 items, range 0-16). A total cognitive functioning score is calculated as the sum of the four subscales. Higher scores indicate fewer cognitive difficulties.
Baseline (Week 0), Week 4, Week 8, Week 12
Change from Baseline in the Visual Analogue Scale (VAS) Score for Cancer/Treatment-Related Pain
The VAS intensity rating consists of a 10-cm line with the endpoints "no pain" and "worst pain". Study participants are asked to make a mark on the line that represents their current pain intensity, and the VAS pain intensity level is scored by measuring the distance from the "no pain" end of the line in millimeters.
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI consists of 18 items. Its global score ranges from 0 to 21, with higher scores indicating poor sleep quality and high sleep disturbance.
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Brief Fatigue Inventory-Chinese Version (BFI-C) Score
The BFI-C consists of 9 items. Its total score ranges from 0 to 10, with higher scores indicating greater fatigue.
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) Score
The HADS-A consists of 7 items. Its total score ranges from 0-21, with higher scores indicating more severe anxiety.
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Change from Baseline in the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) Score
The HADS-D consists of 7 items. Its total score ranges from 0-21, with higher scores indicating more severe depression.
Baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12
Acupuncture Expectation Evaluation
We will assess their expectations of acupuncture by asking questions after the first treatment. Participants will be asked two questions: "Do you think acupuncture may be effective?" and "Do you think acupuncture may be helpful for improving psychoneurological symptoms?". Their responses (Yes, No, or I don't know) will be collected for statistical analysis to evaluate the participants' expectations of acupuncture.
Within 5 minutes after the first treatment
Blinding assessment
To evaluate the success of blinding among participants in this study, blinding assessment will be performed. Specifically, participants will be asked a specific question within 5 minutes after the first treatment and again within 5 minutes after the last treatment to ascertain their awareness of their group assignment.
Within 5 minutes after the first treatment， Within 5 minutes after the last treatment
Safety Assessment
The occurrence of acupuncture-related and general adverse events (including serious adverse events \[SAEs\]) is documented in detail throughout the study.
The entire study period (Week 0 [Baseline] to Week 12 [Follow-up])
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  1. Female, aged 18-75 years;
  2. Histologically confirmed Stage 0, I, II, or III breast cancer (according to the AJCC 8th edition)；
  3. Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least 1 month prior to study initiation , and are currently receiving endocrine therapy；
  4. Meet at least 2 of the following 6 criteria:

(1)Visual Analogue Scale (VAS) score for pain ≥ 4 (2)Pittsburgh Sleep Quality Index (PSQI) score ≥ 8 (3)Brief Fatigue Inventory-Chinese version (BFI-C) score ≥ 4 (4)Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score ≥ 8 (5)Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score ≥ 8 (6)Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments (FACT-Cog-PCI) score < 60 ; 5.Has signed the informed consent form and voluntarily participates in this study.

  1. History of psychiatric disorders (e.g., bipolar disorder, schizophrenia, substance addiction)
  2. Presence of diseases that may impair cognitive function or interfere with study assessments (e.g., Alzheimer's disease, Parkinson's disease, brain tumors).
  3. Fatigue attributable to a treatable condition (e.g., hypothyroidism).
  4. Severe debilitation or significant organic disease (e.g., heart failure, severe hepatic/renal insufficiency, severe anemia, uncontrolled infection).
  5. Use of anxiolytics, antidepressants, psychostimulants, or sedative-hypnotics within the past 4 weeks.
  6. Chronic use of corticosteroids.
  7. Prior acupuncture treatment within 3 months, or participation in an acupuncture or drug clinical trial within 6 months.
  8. History of hemorrhagic disease, severe coagulation dysfunction, or current use of anticoagulants (e.g., warfarin).
  9. Implanted cardiac pacemaker.
  10. Pregnancy or breastfeeding.
  11. Concurrent participation in another clinical study.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine logoFirst Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study Responsible Party
Yan Shiyan, Principal Investigator, Principal Investigator, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study Central Contact
Contact: Shiyan Yan, +86 22 27986078, [email protected]
Contact: Ruihan Guo, +86 135 2033 6216, [email protected]
6 Study Locations in 1 Countries

Beijing Municipality

Senior Department of Oncology，Chinese PLA General Hospital, Beijing, Beijing Municipality, 100039, China
Hua Song, PhD, Contact, +86 10-66947798, [email protected]
Shaohua Zhang, PhD, Principal Investigator
Xiyuan Hospital of CACMS, Beijing, Beijing Municipality, 100091, China
JuLing Jiang, Contact, +86 10 62835438, [email protected]
ZhongNing Guo, PhD, Principal Investigator

Jiangsu

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University), Nanjing, Jiangsu, 210029, China
Jing Lu, Contact, +86 25 68306522, [email protected]
Jing Lu, PhD, Principal Investigator

Shandong

Qingdao Traditional Chinese Medicine Hospital, Qingdao Hiser Hospital Affiliated of Qingdao University, Qingdao, Shandong, 266000, China
YiBo He, Contact, +86 532 83777906, [email protected]
Bo Liu, PhD, Principal Investigator

Tianjin Municipality

Tianjin Medical University Cancer Institute & Hospital (TMUCIH), Tianjin, Tianjin Municipality, 300060, China
Bin Wang, PhD, Contact, +86 22 23340123-6417, [email protected]
Bin Wang, PhD, Principal Investigator
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin Municipality, 300381, China
ZiYu Kuang, PhD, Contact, +86 22 27986525, [email protected]
FanMing Kong, PhD, Principal Investigator